Associate Clinical Trial Manager

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At Exact Sciences, we're helpingchange how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

The Associate Clinical Trial Manager (ACTM) is responsible for supporting the management, planning, execution, and closure of clinical studies. The ACTM works collaboratively and cross-functionally in an exciting, fast paced environment to support the day-to-day operations of assigned clinical studies and ensure the successful execution of the company's clinical research plans.

This position may be remote.

Essential Duties

Include, but are not limited to, the following:

• Support the coordination and management of operational aspects of a study including planning, start-up, enrollment and close out activities ensuring that deliverables are completed on time and in compliance with department procedures, applicable regulations and quality standards.
• Participate in the preparation, review and implementation of study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, vendor management plans and other essential clinical study documents.
• Support planning and management of systems and materials required to support the execution of clinical studies.
• Maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances to department management.
• Support study database development by reviewing and contributing to case report form (CRF) design, user acceptance testing (UAT), and CRF completion guideline development.
• Support sample management activities including planning, sample handling, kit supply management, sample shipping, sample processing, and resulting.
• Support the identification, selection, start-up and performance monitoring of clinical research sites.
• Support site contracting and study budget management including facilitation of site contract and budget negotiations, invoice review and approval, accrual management and maintenance of budget tracking tools.
• Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance, and ensures compliance with study plans such as the study protocol, monitoring plans, and recruitment plans.
• Conduct monitoring activities as needed.
• Assist in the closure of studies including planning & facilitation of database lock, site & IRB/EC closure, statistical analysis and clinical study report development.
• Support the management and oversight of vendors providing support to clinical studies.
• Provide proactive communication, coordination, and support to sites and members of the cross-functional study team. Actively participate in various team meetings. Interact with investigators and site staff, vendors, key opinion leaders and consultants.
• Support ongoing study audit readiness and participate in internal or regulatory authority audits.
• Provide guidance and support to less experienced team members.
• Participate or may facilitate department or project initiatives under the direction of management or a lead clinical trial manager.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
• Ability to attend off-site meetings and conferences as needed.

Minimum Qualifications

• Bachelor's Degree in Life Sciences or field as outlined in the essential duties.
• 3+ years of experience in clinical research.
• Clinical monitoring experience or oversight including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits.
• Experience writing, reviewing and editing protocols.
• Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research.
• Proficiency in Microsoft Office programs, such as: Word, Excel, PowerPoint, Outlook, Teams, SharePoint, or MS Project.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Experience participating in the qualification and management of external vendors (e.g. CRO, central labs, call centers, Decentralized Clinical Trial (DCT) providers)
• Experience contributing to project teams through the start-up, study conduct, and data management.
• International study experience, IVDR, and GDPR implementation
• Working knowledge of the FDA submission process including IDE, PMA, and 510(k).
• Experience as a study coordinator or clinical research associate.
• Sample management system experience.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

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